TRUE DILATATION CATHETER 0204511

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-02-15 for TRUE DILATATION CATHETER 0204511 manufactured by Bard Peripheral Vascular, Inc..

Event Text Entries

[100182787] No hospital/medical records or medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10


[100182788] It was reported that during an aortic valvuloplasty procedure, the balloon catheter allegedly aspirated air at the plastic bifurcation. The balloon was exchanged over the guidewire for another that was used to complete the procedure. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020394-2018-00111
MDR Report Key7274020
Report SourceDISTRIBUTOR,FOREIGN
Date Received2018-02-15
Date of Report2018-04-09
Date of Event2018-01-18
Date Mfgr Received2018-03-27
Device Manufacturer Date2017-07-26
Date Added to Maude2018-02-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJUDITH LUDWIG
Manufacturer Street1625 W 3RD ST.
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1C.R. BARD, INC. (GFO)
Manufacturer Street289 BAY ROAD
Manufacturer CityQUEENSBURY NY 12804
Manufacturer CountryUS
Manufacturer Postal Code12804
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRUE DILATATION CATHETER
Generic NameBALLOON VALVULOPLASTY CATHETER
Product CodeOZT
Date Received2018-02-15
Returned To Mfg2018-02-06
Catalog Number0204511
Lot NumberGFBV3890
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBARD PERIPHERAL VASCULAR, INC.
Manufacturer Address1625 W 3RD ST. TEMPE AZ 85281 US 85281


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-15

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